Pfizer-BioNTech Comirnaty COVID-19 vaccine
All COVID-19 vaccines authorized in Canada are proven safe, effective and of high quality.
Name: Pfizer-BioNTech Comirnaty® COVID-19 vaccine
Manufacturer: BioNTech Manufacturing GmbH
Status: Approved by Health Canada
Approved for: Age 12 and older
How it's given: Injection in muscle (usually the upper arm)
Number of doses: 2 doses
Note: The Pfizer-BioNTech COVID-19 vaccine was authorized for use in Canada under the Interim Order respecting the importation, sale and advertising of drugs for use in relation to COVID-19. The interim order expired on September 16, 2021. On this date, Pfizer-BioNTech Comirnaty® transitioned to an authorization under the Food and Drug Regulations.
On this page
- Who the vaccine is approved for
- Vaccine ingredients
- Possible side effects
- Vaccine review, approval and monitoring
- Get vaccinated
Who the vaccine is approved for
The vaccine is approved for people who are 12 years of age and older. Its safety and effectiveness in people younger than 12 years of age have not yet been established.
Clinical trials showed that beginning 1 week after the second dose, the Pfizer-BioNTech Comirnaty® COVID vaccine was about:
- 95% effective in protecting trial participants from COVID-19 for those 16 years and older
- 100% effective for those 12 to 15 years old
This vaccine requires 2 doses for maximum protection.
The dosing schedule approved by Health Canada is to give the 2 doses 21 days apart, based on evidence from clinical trials.
Your province or territory decides when people receive their first and second doses of the vaccine.
These decisions are based on public health recommendations and the latest evidence.
Mixed dose schedules
A different vaccine may be offered for your second dose. For example, you may have received Pfizer-BioNTech Comirnaty® as your first dose and be offered Moderna Spikevax® as your second. This is known as a mixed vaccine series.
The National Advisory Committee on Immunization (NACI) recommends an mRNA vaccine (Pfizer-BioNTech Comirnaty® or Moderna Spikevax®) should be offered for your second dose.
Learn more about:
- ALC-0315 = ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate)
- ALC-0159 = 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide
- dibasic sodium phosphate dihydrate
- monobasic potassium phosphate
- potassium chloride
- sodium chloride
- water for injection
Possible side effects
After getting vaccinated, it's common to have temporary side effects. These can last a few hours to a few days after vaccination.
This is the body's natural response, as it's working hard to build protection against the disease.
Common vaccine side effects may include:
|Symptoms at the injection site, such as:||Flu-like symptoms, such as:|
Rare vaccine side effects
Rare reactions that have been reported and confirmed after taking a mRNA vaccine are:
A severe allergic (anaphylaxis) reaction following vaccination is also rare. Signs and symptoms of anaphylaxis may include:
- hives (bumps on the skin that are often very itchy)
- swelling of the lips, face, tongue or airway
- difficulty breathing
- increased heart rate
- loss of consciousness
- sudden low blood pressure
- abdominal pain, vomiting and diarrhea
Call emergency services if you develop or witness any serious symptoms that could be an allergic reaction after vaccination.
Talk to your doctor about any serious allergies or health conditions you may have before you get a vaccine.
This vaccine does not contain common food allergens, such as eggs, shellfish, gluten or nuts.
Reporting a possible serious reaction
Contact your health care provider if you experience:
- a side effect following vaccination with a COVID-19 vaccine
- any persistent, new or worsening symptoms
Health care providers must report possible reactions following vaccination to their local public health authority. The public health authority then reports them to the Public Health Agency of Canada.
Reported allergic reactions and side effects to COVID-19 vaccines are published weekly in our Reported side effects following COVID-19 vaccination report.
Vaccine review, approval and monitoring
Health Canada's independent drug review process is recognized around the world for its high standards and rigor. Our decisions are based only on scientific and medical evidence showing that vaccines are safe and effective. The benefits must also outweigh any risks.
Find detailed technical information such as the product monograph and the regulatory decision summary:
As COVID-19 vaccines are administered across Canada, our safety monitoring is ongoing. The Public Health Agency of Canada, Health Canada, and provincial and territorial health authorities continue to:
- monitor the use of all COVID-19 vaccines closely
- examine and assess any new safety concerns
Learn about the side effects we're currently monitoring.
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